Licensing of antirheumatic drugs: Are the EMA and FDA on the same page?

Author:

Bannwarth Bernard,Berdaï Driss,Kostine Marie

Publisher

Elsevier BV

Subject

Rheumatology

Reference15 articles.

1. Regulatory review of novel therapeutics–Comparison of three regulatory agencies;Downing;New England Journal of Medicine,2012

2. European Medicines Agency. Committee for medicinal products for human use (CHMP) opinion following an article 6(12) referral. Arcoxia. http://www.ema.europa.eu (Doc. Ref.: EMA/438258/2008).

3. COX-2 in play at the AHA and the FDA;FitzGerald;Trends Pharm Sci,2007

4. Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison;Cannon;Lancet,2006

5. Nonsteroidal anti-inflammatory drugs in rheumatoid arthritis and osteoarthritis. Support for the concept of responders and nonresponders;Walker;Arthritis and Rheumatism,1997

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